QA Manager

Posted 03 Sep 2020

Beijing - all, Beijing - China

Req Id 209040

Details

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

 

1. To establish and maintain Quality Operation System based on company Standards and China GSP regulations including drug and medical device products

    a. Establish and update quality operation related SOP/WI according to global standards and local regulation / business needs

    b. Lead deviation management including the training to all internal and external staff 

    c. Lead local recall management including yearly mock recall

    d. Ensure quality performance as defined KPIs and reflected in country quality report

2. Product disposition management to ensure quality products sales to market, including

    a. Establish and maintain product quality standards, product profiles

    b. Establish and maintain inspection plans according to Merck requirements and local regulations

    c. Ensure the effective implementation of inspection and disposition

3. Primary and Secondary transportation management

    a. Establish and maintain shipping specification for all temperature sensitive products

    b. Management of Right First Time (RFT)

    c. Ensure timely temperature evaluation, monitoring, reporting

    d. Qualification and Route validation management

4. 3PL (3rd Party Logistic) & Importer & Forwarer management

    a. Routine Warehouse Management according to quality and business requirements and related regulations

    b. Lead the regular communication and on-site inspections to 3PLs, importers and forwarders with business counterpart to ensure the quality operation meeting the requirements and regulation

    c. Establish and maintain appropriate KPI for performance evaluation and continuous improvements

    d. Communication with internal and external stakeholders to ensure the operature process running efficient and effective

5. Management of Health Authority QC testing for imported products

    a. Ensure proactive planning for reference standards and testing materials needed for importation testing by HA

    b. Ensure timely purchasing, storage and providing of the testing substances and materials

    c. Provide technical support as requested from importer and HA

    d. Maintain regular communication with importer and HA for QC testing issues and new requirements

6. As SAP KU to ensure the proper quallty operation executed in system and provide technical support to related staff

7. As representative of Subsidiary Quality to communication with global for routine quality operation matter and global projects

 

Who you are: 

  • Bachelor degree or above in pharmacy, biology, chemistry or relevent
  • Licensed pharmacist
  • At least 5-10 years working in pharmaceutical manufacturing and/or distribution areas
  • Experience of woking in Quality Management and/or Quality Operation in multi-national companies is preferred
  • Good English skill at reading, writing, speaking and listening
  • SAP and TrackWise experience is preferred

 

Professional & Technical Skills

  • Good communication skill with internal and exteranl partners
  • Professional knowledge in GDP/GSP/GMP, Medical Device
  • Collaboration and Team work 
  • Self-motivation

 

HR: 95598

Functional Area: Quality


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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